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NCT03219333 · OUTCOME

PK Parameter for Enfortumab Vedotin: Area Under Concentration-Time Curve (AUC) (Serum)

A Study of Enfortumab Vedotin for Patients With Locally Advanced or Metastatic Urothelial Bladder Cancer · Source last updated 2024-08-27

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
GEOMETRIC_MEAN
Unit
Day*microgram per milliliter
Interval / dispersion
Geometric Coefficient of Variation
Time frame
AUC0-7 was assessed (in cycles 1 and 2) based on concentration data from Day 1 to Day 8 (pre dose) and AUC0-14 was assessed based on data from D15 (pre dose) to D29 (pre-dose)

What was measured

AUC was derived from the PK blood samples collected.

Analysis population: PK analysis set: all participants who received enfortumab vedotin and from whom at least one blood sample was collected and assayed for enfortumab vedotin, monomethyl auristatin E (MMAE) or total antibody (Tab) concentration. Corresponding records of the time of dosing and sample collection must also be available for all enfortumab vedotin. Here, 'Number Analyzed'= participants evaluable at specified timepoints.

Groups in this outcome

Enfortumab Vedotin - Cohort 1

Participants in Cohort 1 had received prior treatment with platinum-containing chemotherapy. Enfortumab vedotin, at a dose of 1.25 mg/kg, was administered to participants as an IV infusion over approximately 30 minutes on Days 1, 8, and 15 of each 28-day cycle.

Enfortumab Vedotin - Cohort 2

Participants in Cohort 2 had received no platinum-containing chemotherapy were ineligible for treatment with cisplatin at the time of enrollment. Enfortumab vedotin, at a dose of 1.25 mg/kg, was administered to participants as an IV infusion over approximately 30 minutes on Days 1, 8, and 15 of each 28-day cycle.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Enfortumab Vedotin - Cohort 1120
Enfortumab Vedotin - Cohort 287

Reported measurements

7-day post-infusion AUC (AUC(d0-7)) - Cycle 1, Day 1

Analysis denominator · Participants

GroupSource count
Enfortumab Vedotin - Cohort 1115
Enfortumab Vedotin - Cohort 285
Values in Day*microgram per milliliter · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Enfortumab Vedotin - Cohort 134.634.0Not reportedNot reportedNot reported
Enfortumab Vedotin - Cohort 233.541.4Not reportedNot reportedNot reported
AUC(d0-7) - Cycle 1, Day 8

Analysis denominator · Participants

GroupSource count
Enfortumab Vedotin - Cohort 188
Enfortumab Vedotin - Cohort 263
Values in Day*microgram per milliliter · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Enfortumab Vedotin - Cohort 131.343.8Not reportedNot reportedNot reported
Enfortumab Vedotin - Cohort 226.346.0Not reportedNot reportedNot reported
AUC(d0-7) - Cycle 2, Day 1

Analysis denominator · Participants

GroupSource count
Enfortumab Vedotin - Cohort 1104
Enfortumab Vedotin - Cohort 272
Values in Day*microgram per milliliter · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Enfortumab Vedotin - Cohort 136.436.7Not reportedNot reportedNot reported
Enfortumab Vedotin - Cohort 232.030.0Not reportedNot reportedNot reported
AUC(d0-7) - Cycle 2, Day 8

Analysis denominator · Participants

GroupSource count
Enfortumab Vedotin - Cohort 188
Enfortumab Vedotin - Cohort 256
Values in Day*microgram per milliliter · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Enfortumab Vedotin - Cohort 135.941.2Not reportedNot reportedNot reported
Enfortumab Vedotin - Cohort 227.835.8Not reportedNot reportedNot reported
14-day post-infusion AUC (AUC(d0-14)) - Cycle 1, Day 8

Analysis denominator · Participants

GroupSource count
Enfortumab Vedotin - Cohort 185
Enfortumab Vedotin - Cohort 259
Values in Day*microgram per milliliter · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Enfortumab Vedotin - Cohort 134.744.7Not reportedNot reportedNot reported
Enfortumab Vedotin - Cohort 230.947.5Not reportedNot reportedNot reported
AUC(d0-14) - Cycle 2, Day 15

Analysis denominator · Participants

GroupSource count
Enfortumab Vedotin - Cohort 182
Enfortumab Vedotin - Cohort 260
Values in Day*microgram per milliliter · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Enfortumab Vedotin - Cohort 141.240.4Not reportedNot reportedNot reported
Enfortumab Vedotin - Cohort 233.136.6Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        34.0
        value
        34.6
      2. group Id
        OG001
        spread
        41.4
        value
        33.5
    denoms
    1. counts
      1. group Id
        OG000
        value
        115
      2. group Id
        OG001
        value
        85
      units
      Participants
    title
    7-day post-infusion AUC (AUC(d0-7)) - Cycle 1, Day 1
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        43.8
        value
        31.3
      2. group Id
        OG001
        spread
        46.0
        value
        26.3
    denoms
    1. counts
      1. group Id
        OG000
        value
        88
      2. group Id
        OG001
        value
        63
      units
      Participants
    title
    AUC(d0-7) - Cycle 1, Day 8
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        36.7
        value
        36.4
      2. group Id
        OG001
        spread
        30.0
        value
        32.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        104
      2. group Id
        OG001
        value
        72
      units
      Participants
    title
    AUC(d0-7) - Cycle 2, Day 1
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        41.2
        value
        35.9
      2. group Id
        OG001
        spread
        35.8
        value
        27.8
    denoms
    1. counts
      1. group Id
        OG000
        value
        88
      2. group Id
        OG001
        value
        56
      units
      Participants
    title
    AUC(d0-7) - Cycle 2, Day 8
  5. categories
    1. measurements
      1. group Id
        OG000
        spread
        44.7
        value
        34.7
      2. group Id
        OG001
        spread
        47.5
        value
        30.9
    denoms
    1. counts
      1. group Id
        OG000
        value
        85
      2. group Id
        OG001
        value
        59
      units
      Participants
    title
    14-day post-infusion AUC (AUC(d0-14)) - Cycle 1, Day 8
  6. categories
    1. measurements
      1. group Id
        OG000
        spread
        40.4
        value
        41.2
      2. group Id
        OG001
        spread
        36.6
        value
        33.1
    denoms
    1. counts
      1. group Id
        OG000
        value
        82
      2. group Id
        OG001
        value
        60
      units
      Participants
    title
    AUC(d0-14) - Cycle 2, Day 15
denoms
  1. counts
    1. group Id
      OG000
      value
      120
    2. group Id
      OG001
      value
      87
    units
    Participants
description
AUC was derived from the PK blood samples collected.
dispersion Type
Geometric Coefficient of Variation
groups
  1. description
    Participants in Cohort 1 had received prior treatment with platinum-containing chemotherapy. Enfortumab vedotin, at a dose of 1.25 mg/kg, was administered to participants as an IV infusion over approximately 30 minutes on Days 1, 8, and 15 of each 28-day cycle.
    id
    OG000
    title
    Enfortumab Vedotin - Cohort 1
  2. description
    Participants in Cohort 2 had received no platinum-containing chemotherapy were ineligible for treatment with cisplatin at the time of enrollment. Enfortumab vedotin, at a dose of 1.25 mg/kg, was administered to participants as an IV infusion over approximately 30 minutes on Days 1, 8, and 15 of each 28-day cycle.
    id
    OG001
    title
    Enfortumab Vedotin - Cohort 2
param Type
GEOMETRIC_MEAN
population Description
PK analysis set: all participants who received enfortumab vedotin and from whom at least one blood sample was collected and assayed for enfortumab vedotin, monomethyl auristatin E (MMAE) or total antibody (Tab) concentration. Corresponding records of the time of dosing and sample collection must also be available for all enfortumab vedotin. Here, 'Number Analyzed'= participants evaluable at specified timepoints.
reporting Status
POSTED
time Frame
AUC0-7 was assessed (in cycles 1 and 2) based on concentration data from Day 1 to Day 8 (pre dose) and AUC0-14 was assessed based on data from D15 (pre dose) to D29 (pre-dose)
title
PK Parameter for Enfortumab Vedotin: Area Under Concentration-Time Curve (AUC) (Serum)
type
SECONDARY
unit Of Measure
Day*microgram per milliliter

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